METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS

K113271 · Biomet Manufacturing, Inc. · KWA · May 18, 2012 · Orthopedic

Device Facts

• Record ID: K113271
• Device Name: METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
• Applicant: Biomet Manufacturing, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

Device Story

Metal-on-metal hip prosthesis components provide total hip replacement via direct metal-to-metal articulation; consists of metal femoral head prostheses (monolithic or modular) articulating with highly congruent mating acetabular components; eliminates need for ceramic or polyethylene liners. Used in orthopedic surgery for total hip arthroplasty; implanted by surgeons. This submission updates labeling with additional contraindications for previously cleared components to ensure safe use in appropriate patient populations.

Clinical Evidence

No clinical data provided; submission is for labeling update only.

Technological Characteristics

Metal-on-metal hip prosthesis components; femoral head prostheses (monolithic or modular) and acetabular components; direct metal-to-metal articulation; uncemented or cemented use; semi-constrained design.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck fracture, and trochanteric fractures of the proximal femur. M2a-Magnum system also indicated for diastrophic variant, pelvic fracture, fused hip, Legg Perthes, slipped capital epiphysis, subcapital fractures, and traumatic arthritis. Used in primary and revision hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Metal-On-Metal Acetabular Component (K993438)
• M2a Ringloc Acetabular Liner (K002379)
• M2a Acetabular System (K011110)
• M2a Magnum System (K042037)
• M2a / C2a Acetabular System (K042841)
• M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads (K061423)
• M2a Magnum Tri-Spike Acetabular Component (K062995)
• Biomet Metal Systems - Expanded Contraindications (K082446)

Submission Summary (Full Text)

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K 113271 (pg. 1 of 3)

ੇ ਜ਼ਿੰਦੂ ਹੈ।

ਹੈ ਜਾਣ ਵਿੱਚ ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਸ . ORTHOPEDICS

### 510(k) Summary

MAY 1 8 2012

Preparation Date:

28 October, 2011

56 East Bell Drive P.O. Box 587

Biomet Manufacturing Corp.

Warsaw, Indiana 46581-0587

Applicant/Sponsor:

Contact Person:

Gary Baker, MS RAC Senior Regulatory Specialist Biomet Orthopedics LLC. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: [phone] Ext. 1568 Fax: [phone] [e-mail]

Metal-on-Metal Hip prosthesis

FDA Registration Number: 1825034

Proprietary Name:

Common Name:

Classification Name:

KWA (888.3330). Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (888.3330)

Metal-On-Metal Hip Systems - Additional Contraindications

LPH (888.3358), Hip joint metal/polymer/metal semi-constrained, porous-coated uncemented prosthesis.

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K993438 - Metal-On-Metal Acetabular Component

- K002379 M2a Ringloc Acetabular Liner
- K011110 M2a Acetabular System

K042037 - M2a Magnum System

K042841 - M2a / C2a Acetabular System

K061423 - M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads

K062995 - M2a Magnum Tri-Spike Acetabular Component

K082446 - Biomet Metal Systems - Expanded Contraindications

Malling Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: [phone] www.biomet.com

Shipping Address: 56 E. Bell Drive Warsaw, IN 46582

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K113271 (pg. 2 of 3)

### Device Description:

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.

This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

### Intended Use:

Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

#### Indications for Use:

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

- 2. Rheumatoid arthritis.
3. Correction of functional deformity.

- (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and 4. M2a-RinglocTM).
(b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

### Summary of Technologies:

The technological characteristics are the same as those included in the predicate Metal-On-Metal · 510(k)s already cleared for marketing.

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#### 从113271 89. 3

# Non-Clinical Testing:

Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices.

## Clinical Testing:

Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 8 2012

Biomet Manufacturing Corp. % Mr. Gary Baker 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K113271

Trade/Device Name: Metal-on-Metal Hip Systems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH Dated: May 14, 2012 Received: May 16, 2012

Dear Mr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Gary Baker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Marti A. Millkinson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Page 1 of 1 :

510(k) Number (if known): H | | 32 7 |

Device Name: Biomet Metal-On-Metal Total Hip Replacement

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and 4. M2a-RinglocTM).

(b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milhurn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

5